De Braekeleer K, Fierens C, Corthout J
Service de Contrôle des Médicaments APB, Bruxelles.
J Pharm Belg. 2009 Dec(4):141-6.
Nifedipine preparations formulated as immediate-release capsules and prolonged-release tablets were evaluated with different tests, including in vitro dissolution, assay and content uniformity, and determination of related compounds. The analytical methods were previously validated according to international guidelines. All examined products complied with the postulated requirements but the dissolution test for prolonged-release tablets showed that these products cannot be interchanged.
对制成速释胶囊和缓释片的硝苯地平制剂进行了不同测试评估，包括体外溶出度、含量测定和含量均匀度以及有关物质的测定。分析方法先前已根据国际指南进行验证。所有检验的产品均符合假定要求，但缓释片的溶出度测试表明这些产品不能互换。
